DEVELOPMENT AND VALIDATION OF NOVEL RP-UHPLC/ DAD METHODS FOR SIMULTANEOUS QUANTIFICATION OF REMOGLIFLOZIN AND METFORMIN IN BULK AND FORMULATION

Abstract

For the treatment of diabetes mellitus, a new formulation containing remogliflozin etabonate (REMO) and metformin HCl (MET) has recently been approved. This study is aimed to develop simple and quick RP-UHPLC methods for measuring REMO and MET simultaneously. REMO and MET chromatographic separation were carried out on a Zorbax Eclipse Plus C18 (150×4.6 mm, 5 μm) column with acetonitrile: phosphate buffer (pH: 3) (60:40 %, v/v) mobile phase, 10 μl sample volume and 1.0 ml/min flow rate at 230 nm in a diode array detector. REMO had a 99.51 % average percent assay, while MET had a 99.60 % average percent assay. The methods projected were simple, precise, accurate, and fast. They can also be used to verify the consistency of REMO and MET formulations regularly.